FDA 510(k) Application Details - K974441

Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)

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510(K) Number K974441
Device Name Sunglasses (Non-Prescription Including Photosensitive)
Applicant HIP SHING FAT CO., LTD.
1829-1832 STAR HOUSE, TST
KOWLOON HK
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Contact PETER K C. LEE
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Regulation Number 886.5850

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Classification Product Code HQY
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Date Received 11/25/1997
Decision Date 01/09/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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